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Director CMC Monoclonal Antibodies & Antibody-Drug Conjugates

Mainz, Germany   |   full time   |   Job ID: 9778 

 

 

The Director CMC will play a key role by leading complex scientific development projects from pre-clinical stage to commercialization in the area of ADCs (antibody-drug conjugates). Being accountable for the projects, the Director CMC together with the CMC team will create integrated CMC project plans, track progress, identify and manage risks, and communicate across all levels of the organization. In this role you will represent the CMC team in the cross-functional program core team and will synchronize the clinical projects with drug substance, drug product t and analytical development activities within the global organization. In collaboration with internal departments, you will provide strategic and scientific input in the development projects and programs. In addition, and if applicable, the Director CMC will serve as the liaison and key contact for Collaboration Partners and Contract Development and Manufacturing Organization partners.

 

Your main responsibilities are:

 

  • Collaborate with internal and/or external technical leads and experts (Process Development, Analytical Development, Quality, Regulatory, Supply Chain, Commercial) to develop detailed CMC project plans to successfully progress an asset from pre-clinical through clinical phase up to commercialization
  • Lead the scientific and technical assessment of development projects related to all CMC aspects as the CMC project lead
  • Oversee CMC timelines and budget; bring focus to risk management activities and implement processes to identify risks, maintain risk registry and proactively execute mitigation plans to help ensure effective project execution
  • Drive timely and data-driven decision making, and facilitate strategic discussions within CMC and with internal and external partners
  • Drive continuous improvement of process and data quality, through streamlining and optimizing processes

 

What you have to offer: 

 

  • An advanced degree (PhD or relevant multi-year practice) in Pharmacy, Chemistry, Biotechnology, Biochemistry or Biology with at least 8 years professional experience in an international, pharmaceutical environment
  • Sound knowledge of working in different scientific/technical CMC development functions (process development, pharmaceutical and/or analytical development, manufacturing). Documented experience in CMC regulatory affairs would be a plus
  • In depth CMC development knowledge in either early or late-stage projects with sound understanding of all stages of drug development and GMP; Experience with ADC development and regulatory filings (IND/IMPD, BLA/MAA) is considered a plus
  • Leadership, seniority and assertiveness, capable of leading CMC teams and aligning on the project with other functions and
  • Excellent communication (English fluent; German is a plus) and negotiation skills and ability to clearly and concisely communicate complex technical matters to core team and senior management; Experience in defining and executing strategy; Management of multiple, parallel tasks and maintaining focus in a complex, fast-paced environment

 

 

 

 

Your Benefits:

 

It's our priority to support you:

  • Your flexibility: flexible hours | vacation account  
  • Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
  • Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
  • Your health and lifestyle: Company bike
  • Your mobility: Job ticket | Deutschlandticket 
  • Your life phases: Employer-funded pension | Childcare 

 

 

Apply now - We look forward to your application!

 

Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 12 PM to 4 PM CET).

 

Job ID 9778 (please always specify if you have any questions)   

 

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

 

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